US FDA Wants Third-Party Audit for GMP and Compliance of Dr Reddy's Units

The US Food and Drug Administration (FDA) inspected three main Indian facilities of Dr.Reddy’s Laboratory and issued warning letters for facility.

The US Food and Drug Administration (FDA), which had issued a warning letter to Dr Reddy's Laboratories over quality issues two weeks ago, said it might even refuse entry of products into the US from the three plants cited in the letter if the company fails to correct the violations.

Until the company completes all corrections and confirms compliance with current good manufacturing practices, it may withhold approval of new applications, a drug product or active pharmaceutical ingredients, it maintained.

The US drug regulator has suggested corrective actions on each of the critical observations, related to three manufacturing facilities of Dr Reddy’s. FDA in its warning letter dated November 5, asked Dr Reddy’s to conduct third-party audits as part of the compliance exercise, as DRL is getting warning letters for few Indian facilities.

Dr Reddy’s on November, 10 had informed the stock exchange about the US drug regulator’s order. The company spokesperson did not respond to a query about the reference to this previously existed testing lab. Dr Reddy’s president and chief financial officer Saumen Chakraborty said “the sunset clause could be deferred for a few more years, considering the significant investments by the companies, as also the impact of SEZ encountered due to the minimum alternate tax levy”.